Duley Lelia, Dorling Jon, Pushpa-Rajah Angela, Oddie Sam J, Yoxall Charles William, Schoonakker Bernard, Bradshaw Lucy, Mitchell Eleanor J, Fawke Joe Anthony
Nottingham Clinical Trials Unit, Queen's Medical Centre, University of Nottingham, Nottingham, UK.
Early Life Research Group, Queen's Medical Centre, University of Nottingham, Nottingham, UK.
Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F6-F14. doi: 10.1136/archdischild-2016-312567. Epub 2017 Sep 18.
For very preterm births, to compare alternative policies for umbilical cord clamping and immediate neonatal care.
Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes.
Eight UK tertiary maternity units.
261 women expected to have a live birth before 32 weeks, and their 276 babies.
Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping.
Intraventricular haemorrhage (IVH), death before discharge.
132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35 weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) -5.9% (95% CI -12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 47 of 132 (36%), respectively; RD -3.5% (-14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers.
This is promising evidence that clamping after at least 2 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.
ISRCTN 21456601.
针对极早产情况，比较脐带夹闭及新生儿即刻护理的不同策略。
平行组随机（1:1）试验，使用密封不透明编号信封。
英国八家三级产科单位。
预计在32周前活产的261名女性及其276名婴儿。
至少2分钟后夹闭脐带并在脐带完整时进行新生儿即刻护理，或在20秒内夹闭脐带并夹闭后进行新生儿即刻护理。
脑室内出血（IVH）、出院前死亡。
132名女性（137名婴儿）被分配至夹闭≥2分钟且脐带完整时进行新生儿护理组，129名（139名）被分配至夹闭≤20秒且夹闭后进行新生儿护理组；6对母婴二元组被排除（2对、4名），因为出生孕周超过35周，1对退出（仅可得死亡数据）（0对、1名）。分配至夹闭≥2分钟组的中位孕周为28.9周，分配至夹闭≤20秒组的为29.2周。夹闭的中位时间分别为120秒和11秒。分配至夹闭≥2分钟组的135名婴儿中有7名（5.2%）死亡，分配至夹闭≤20秒组的135名中有15名（11.1%）死亡；风险差（RD）为-5.9%（95%置信区间-12.4%至0.6%）。在活产儿中，134名中有43名（32%）发生IVH，而132名中有47名（36%）；RD为-3.5%（-14.9%至7.8%）。婴儿或母亲的其他结局无明显差异。
这是有前景的证据，表明极早产时至少2分钟后夹闭脐带并在脐带完整时进行新生儿即刻护理可能改善结局；迫切需要进行大规模试验。
ISRCTN 21456601。
